What Role Does Clinical Affairs Play in Medical Technology?
Clinical Affairs deals with all issues relating to the clinical benefit of medical devices with the aim of ensuring that the medical device actually provides the clinical benefit when used. Mahsa, Senior Clinical Affairs Manager, has an important position in this area at WEINMANN Emergency. She has been part of the WEINMANN Community since March 2020 and has integrated the area of Clinical Affairs into the company. Together with her colleague Katja, she is responsible for this demanding field of activity. In recent years, she has made a significant contribution to successfully implementing the requirements of the Medical Device Regulation (MDR).
Varied tasks as Clinical Affairs Manager
Mahsa is the point of contact for all queries regarding approval of new and further developments of medical devices. Her main task is to demonstrate the safety and performance as well as the clinical benefit of the medical device during clinical application throughout the entire product life cycle.
From development of clinical approval strategies and creation of clinical evaluations to planning, coordination and evaluation of clinical studies to communication with physicians and the relevant authorizing bodies and ethics commissions – Mahsa makes a significant contribution to safety and efficacy. At the same time, she is responsible for post-market clinical follow-up once the products are on the market and generates clinical data when monitoring the medical device. She works closely with the product managers, risk managers, quality managers, vigilance managers and system architects and acts as an important interface between internal departments and external medical consultants. Working together in this way enables complex challenges to be successfully managed.
The challenges of clinical evaluation in emergency medicine
Clinical evaluation requirements have risen considerably in recent years, due to stricter regulations. WEINMANN Emergency recognized early on that it needs to have an expert like Mahsa on board. This step guarantees that WEINMANN Emergency continues to meet the highest standards and offer innovative solutions in the field of medical technology. Nevertheless, the challenges are extensive. Particularly in the field of emergency medicine, it is difficult to generate clinical data in line with the MDR. Firstly, it is difficult to find physicians for studies with older products, even though this is necessary according to the regulatory requirements. Furthermore, gathering the data of patients unable to give their consent is problematic. “One possible approach is to carry out in-clinic studies, e.g. as part of anesthesia or elective cardioversion. We are working intensively on this”, explains Mahsa.
Focus on continuous process optimization and internal consultation
“In view of the fact that all products receive clinical evaluations and have to be monitored throughout their entire life cycle, I have increasingly focused on process optimization. Continuous internal consultation, in particular regarding clinical questions before, during and after approval of the medical device is also an ongoing process. However, in future I would also like to focus more on making medical and scientific information regarding mechanical ventilation in connection with WEINMANN products marketable to the outside world, for example at congresses,” explains Mahsa.
The joy of working for WEINMANN Emergency
For Mahsa her job is a matter of the heart. Daily communication with people from different fields fills her with excitement. Her job is a continuous challenge, that she masters passionately: “At WEINMANN Emergency, I particularly appreciate the great team spirit and working together with my colleagues. Our regular exchanges not only help us work together effectively, but also create a positive atmosphere that makes the workplace a special place to be appreciated”. Here she can fully indulge in her enthusiasm for challenges and work on innovative solutions together with her colleagues.
